Study in Unsettled Infants Experiencing Feeding Intolerance
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 260
Inclusion Criteria
- Full term infants, singleton, healthy at birth
- Infants exclusively consuming a standard formula for a minimum of 3 consecutive days prior to enrolment.
- Infant's parent(s)/LAR are of legal age of consent and are willing and able to fulfil the requirements of the study protocol.
- ...
- Full term infants, singleton, healthy at birth
- Infants exclusively consuming a standard formula for a minimum of 3 consecutive days prior to enrolment.
- Infant's parent(s)/LAR are of legal age of consent and are willing and able to fulfil the requirements of the study protocol.
- Infants of parent(s)/LAR who have previously made the decision to exclusively formula feed their infant.
Exclusion Criteria
- Infants who are consuming any amount of supplemental human milk
- Infants with known cow's milk allergy or family history of siblings with documented cow's milk protein intolerance/allergy
- Infants who have a medical condition or history that could cause or contribute to feeding intolerance
- ...
- Infants who are consuming any amount of supplemental human milk
- Infants with known cow's milk allergy or family history of siblings with documented cow's milk protein intolerance/allergy
- Infants who have a medical condition or history that could cause or contribute to feeding intolerance
- Infants who are consuming weaning foods or beverages other than infant formula
- Infants who received any other investigational intervention or who have participated in another clinical trial prior to enrolment
Summary
- Conditions
- Feeding Disorder
- Type
- Interventional
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 90 years
- Gender
- Both males and females
Description
The purpose of the present study is therefore to evaluate the effect of an experimental formula in an unsettled formula-fed infant population whose parents are considering switching formulas due to perceived feeding intolerance.
The purpose of the present study is therefore to evaluate the effect of an experimental formula in an unsettled formula-fed infant population whose parents are considering switching formulas due to perceived feeding intolerance.
Inclusion Criteria
- Full term infants, singleton, healthy at birth
- Infants exclusively consuming a standard formula for a minimum of 3 consecutive days prior to enrolment.
- Infant's parent(s)/LAR are of legal age of consent and are willing and able to fulfil the requirements of the study protocol.
- ...
- Full term infants, singleton, healthy at birth
- Infants exclusively consuming a standard formula for a minimum of 3 consecutive days prior to enrolment.
- Infant's parent(s)/LAR are of legal age of consent and are willing and able to fulfil the requirements of the study protocol.
- Infants of parent(s)/LAR who have previously made the decision to exclusively formula feed their infant.
Exclusion Criteria
- Infants who are consuming any amount of supplemental human milk
- Infants with known cow's milk allergy or family history of siblings with documented cow's milk protein intolerance/allergy
- Infants who have a medical condition or history that could cause or contribute to feeding intolerance
- ...
- Infants who are consuming any amount of supplemental human milk
- Infants with known cow's milk allergy or family history of siblings with documented cow's milk protein intolerance/allergy
- Infants who have a medical condition or history that could cause or contribute to feeding intolerance
- Infants who are consuming weaning foods or beverages other than infant formula
- Infants who received any other investigational intervention or who have participated in another clinical trial prior to enrolment
Tracking Information
- NCT #
- NCT02021058
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Associate Professor Boosba Vivatvakin, MD Pediatric Department, Faculty of Medicine, Chulalongkorn University
- Associate Professor Boosba Vivatvakin, MD Pediatric Department, Faculty of Medicine, Chulalongkorn University
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